November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.

The purpose of the NHLBI Career Transition Award (K22)
program is to provide highly qualified postdoctoral fellows with an
opportunity to receive mentored research experience in the NHLBI Division of
Intramural Research and then to provide them with funding to facilitate the
transition of their research programs as new investigators to extramural
institutions. To achieve these objectives, the NHLBI Career Transition Award
will support two phases of research: a mentored intramural phase (two
years) and an extramural phase (three years), for a total of five years of
combined support. Transition from the intramural phase of support to the
extramural phase is not automatic. Approval of the transition will be
based on the success of the awardees research program as determined by an
NHLBI progress review, which will include an evaluation of a research plan to
be carried out at the extramural institution.

Key Dates

Posted Date

March 23, 2012

Open Date (Earliest Submission Date)

May 12, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

The objective of the NHLBI Career Transition Award (K22)
program is to enable outstanding postdoctoral individuals to obtain research
training experience in the NHLBI Division of Intramural Research and to
facilitate their successful transition to an extramural environment as
independent researchers. Eligible applicants must agree to be supported by the
NHLBI laboratory or branch for the intramural phase of the program. Applicants
must contact the NHLBI program staff (Section VII.) for guidance and additional
information. Following the intramural phase support, eligible organizations for
the extramural phase of the program are listed under Eligible Applicants in
Section III.

To achieve these objectives, the NHLBI Career Transition
Award will support two phases of research. The award will provide up to two
years of support for mentored research training in an NHLBI intramural
laboratory followed by three years of support for an independent research
project in an extramural institution. It is anticipated that awardees will
subsequently obtain research project grants such as the R01 to support the
continuation of their work.

Transition from the intramural phase of support to the
extramural phase is not automatic. Approval of the transition will be based on
the success of the awardee’s research program as determined by an NHLBI
progress review, which will include an evaluation of a research plan to be
carried out at the extramural institution.

The extramural institution must demonstrate a commitment to
the candidate by providing protected research time and space needed to perform
the proposed research. Supplemental funds from the extramural institution for
equipment and supplies (and if necessary, salary) are encouraged.

Awardees approved to proceed with the second phase of
support will receive notification of approval in writing from the NHLBI. An
application from the extramural institution on behalf of the candidate will be
required for the NHLBI to process the second phase of the K22.

Acceptance into the NHLBI Career Transition Award Program
does not convey any commitment or intent of the NHLBI to consider the awardee
for a tenure track position within the NHLBI. The NHLBI Career Transition Award
is specifically intended to help develop scientists who will pursue their
careers in the extramural biomedical research community. However, the NHLBI K22
awardees are not explicitly precluded from applying for available tenure track
positions at the NIH. If an awardee obtains an NIH position, the NHLBI Career
Transition Award will be terminated.

NHLBI
DIVISION OF INTRAMURAL RESEARCH

The Division of Intramural Research conducts clinical
research on the normal and pathophysiologic functioning of the cardiac,
pulmonary, blood, and endocrine systems and basic research on normal and
abnormal cellular behavior at the molecular level. The research activities of
the laboratories and branches range from structural organic chemistry to cardiology.

Major
areas of interest include:

Mechanisms of gene regulation, viral-mediated gene transfer
and gene therapy, the molecular basis of lipoprotein dysfunctions and the
atherogenic process, the molecular basis of diseases of the alveolar structures
of the lung and the design of new therapeutic modalities, the cellular and
molecular events underlying ischemic heart disease and myocardial hypertrophy,
biochemical events associated with aging and certain pathologic processes,
molecular, structural, and developmental aspects of muscle and nonmuscle
contractile systems, cell and organelle movement, molecular and cellular
processes for the conversion of metabolic energy into useful work, mechanisms
of cardiac development, the molecular basis of transmembrane signaling,
the pathophysiology of renal function at the cellular and molecular levels, the
biochemistry of trace nutrients, enzyme kinetics, metabolic regulation and
protein chemistry, the cellular and molecular basis of toxicities induced by
drugs and other foreign compounds, molecular immunology and cytokines,
hematopoietic stem cell biology and bone marrow transplantation,
pathophysiology of vascular diseases with emphasis on molecular genetic
interventions, cardiac imaging through ultrasound and magnetic resonance
imaging, as well as some aspects of cardiovascular devices, computational
biophysics, and mass and optical spectroscopy. Animal medicine and surgery
support is provided to both clinical and basic science by full-time NHLBI
staff. Potential candidates are urged to visit the web site for the
Division of Intramural Research at NHLBI: https://intramural.nhlbi.nih.gov/default.aspx

Section II. Award
Information

Funding Instrument

Grant

Application
Types Allowed

New
Resubmission

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

Award budgets are composed of salary and other
program-related expenses, as described below.

Award Project Period

The total period of support is five years (two years
intramural, plus three years extramural). Awards are not renewable.

Support for the intramural phase is provided by the
candidate's NHLBI intramural laboratory or branch.

Support for the extramural phase will be provided to the
extramural institution. Total direct costs for the extramural phase cannot
exceed $249,000, including fringe benefits, per year. The total costs cannot
exceed $747,000 for the three-year period.

Other Award Budget
Information

Salary

Intramural
Phase:

Support during the intramural phase will be based on the
candidate's years of postdoctoral experience, commensurate with the NHLBI
intramural salary structure and is provided by the candidate's laboratory or
branch.

Extramural
Phase:

Support for the extramural phase will be provided to the
extramural institution and may not exceed three years in duration. The total
cost for the extramural phase may not exceed $249,000 per year. This amount
includes salary, fringe benefits, research support allowance and applicable
facilities and administrative (F&A) costs (see “Indirect Costs” below). The
total salary requested must be based on a full-time staff appointment. The
salary must be consistent both with the established salary structure at the
institution and with salaries actually provided by the institution from its
own funds to other staff members of equivalent qualifications, rank, and
responsibilities in the department concerned. The sponsoring institution may
supplement the NIH salary contribution up to a level that is consistent with
the institution's salary scale. However, supplementation may not be from
Federal funds unless specifically authorized by the Federal program from
which such funds are derived. In no case may PHS funds be used for salary
supplementation. Institutional supplementation of salary must not require
extra duties or responsibilities that would interfere with the purpose of the
career award.

Other Program-Related Expenses

Support for the extramural phase will be provided to the
extramural institution and may not exceed three years in duration. The total
cost for the extramural phase may not exceed $249,000 per year. This amount
includes salary, fringe benefits, research support allowance and applicable
facilities and administrative (F&A) costs (see “Indirect Costs” below).

Salary for mentors, secretarial and administrative assistants, etc. is not
allowed.

Indirect Costs

For the extramural phase, Indirect Costs (also known as
Facilities & Administrative [F&A] Costs) are reimbursed at 8% of
modified total direct costs. F&A costs requested by consortium
participants are included in the total cost limitation..

NIH grant policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private Institutions
of Higher Education:

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

NHLBI postdoctoral fellows (or individuals who have been
accepted to an intramural postdoctoral position) are invited to work with their
mentors to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support. Multiple Principal
Investigators are not allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have earned a terminal
clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS,
PharmD., or equivalent doctoral degree), or a combined clinical and research
doctoral degree. The candidate must have postdoctoral research experience,
during which the potential for highly productive basic or clinical research was
demonstrated. During the intramural phase of the award, the candidate will
spend full time on research. The required research experience must be completed
in an intramural NIH laboratory.

To obtain support for the extramural phase, at the time of
the award candidates must have a full time formal tenure-track (or equivalent) appointment
offer at the academic institution that is the applicant institution.

Candidates who have VA appointments may not consider part of
the VA effort toward satisfying the full time requirement at the applicant institution.
Candidates with VA appointments should contact the NHLBI staff prior to
preparing an application to discuss their eligibility.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed. An individual may not have two or more competing
NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Individuals are eligible for a K22 award if they have been,
or currently are, the PI of an NIH R03 or R21 grant or a PHS or non-Federal
award that duplicates the provisions or research goals of an R03 or R21 grant.

Individuals are NOT eligible to apply if they have pending
an application for any other PHS career development award, an NIH
institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals
are not eligible to apply if they have been or are currently a PI on an NIH
research grant (such as R01, R29, P01) or a subproject leader on a Program
Project (P01) or Center Grant (P50), or a non-NIH equivalent to these
grants/awards.

Special
Requirements

Acceptance into the NHLBI Career Transition Award Program
does not convey any commitment or intent of the NHLBI to consider the awardee
for a tenure track position within the NHLBI. The NHLBI Career Transition Award
is specifically intended to help develop scientists who will pursue their
careers in the extramural biomedical research community. However, the NHLBI K22
awardees are not explicitly precluded from applying for available tenure track
positions at the NIH.

Once a K22 award is made, the awardee is expected to remain
with the NHLBI Intramural Program for at least 18 months. Exceptions may
be reviewed on a case-by-case basis.

Intramural
Phase:

Mentor(s): The candidate must name a primary sponsor/mentor
who, together with the applicant, is responsible for the planning, direction,
and execution of the program. The mentor must be an investigator at the NHLBI
who is recognized as an accomplished investigator in the proposed research area
and has a track record of success in training research scientists. Candidates
may also nominate co-mentors as appropriate to the goals of the program.
Co-mentors may be NIH investigators or may be full-time faculty at an
extramural institution.

Extramural
Phase:(Provide this information only during the time of
transition to Extramural Phase.)

Sponsoring Extramural Institution: To obtain support
for Extramural Phase, the Intramural Phase awardee must have a formal
tenure-track (or equivalent) offer at the extramural institution. The
institution must demonstrate a commitment to the individual by providing
protected research time and space needed to conduct the proposed research.

The sponsoring institution must document a strong,
well-established research and career development program related to the
candidate’s area of interest, including a high-quality research environment
with key faculty members and other investigators capable of productive
collaboration with the candidate.

Describe the sponsoring institution’s scientific environment
including the resources and facilities that will be available to the candidate.

Describe how the institutional research environment is
particularly suited for the development of the candidate’s research career and
the pursuit of the proposed research plan and progression to the extramural phase
as an independent investigator.

K22 award recipients are expected to apply for NIH or other
independent research grant support during the extramural phase of the award.
Recipients may hold concurrent research support and under certain circumstances
salary support from the final two years of their K22 award and a competing NIH
research project grant when recognized as the PD/PI or subproject Director of
the research project grant. See NOT-OD-08-065.

Level of Effort

At the time of award, the candidate must have a “full-time”
appointment at the academic institution that is the applicant institution. Awardees
must be able to commit a minimum of nine person-months conducting
research career development activities associated with this award. The
remaining three person-months (can be divided among other research,
clinical, and teaching activities only if these activities are consistent with
the goals of the K22 award. For information regarding NIH policy on determining
full-time professional effort for career awards, see NOT-OD-04-056.
Candidates who have VA appointments may not consider part of the VA effort
toward satisfying the “full time” requirement at the applicant institution.
Candidates with VA appointments should contact the staff person in the relevant
Institute or Center prior to preparing an application to discuss their
eligibility. Under certain circumstances, an awardee may submit a written
request to the awarding component requesting a reduction in minimum required
percent effort, which will be considered on a case-by-case basis. Details on
this policy are provided in NOT-OD-09-036.

Mentor(s)

Before submitting the application, the candidate must
identify a mentor who will supervise the proposed career development and
research experience. The principal mentor should be an NHLBI Intramural
investigator in the area of the proposed research and be committed both to the
career development of the candidate and to the direct supervision of the
candidate’s research. The mentor, or a member of the mentoring team, should
have a successful track record of mentoring. Candidates are encouraged to
identify more than one mentor, i.e., a mentoring team, if this is deemed
advantageous for providing expert advice in all aspects of the research career
development program. In such cases, one individual must be identified as the
principal mentor who will coordinate the candidate’s research. The candidate
must work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate
(coordinated with the candidate’s research strategy). The description of the
career development plan should include items such as classes, seminars, and
opportunities for interaction with other groups and scientists. Training in
career skills, e.g.,
grant-writing and making effective presentations, is strongly encouraged. The mentor
and any co-mentors are also expected to provide an assessment of the
candidate’s qualifications and potential for a research career. The research
environment and the availability and quality of needed research facilities and
research resources (e.g., equipment, laboratory space, computer time, available
research support, etc.) must also be described.

Section IV. Application
and Submission Information

1. Requesting an Application
Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow the instructions in the SF 424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Other Project Information Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Project Summary/Abstract (Component
of the Other Project Information Component)

This attachment must be uploaded via the Other
Project Information Component, and must include a description of your current
research and the research you propose to continue in the extramural phase.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Candidate’s Background (Component of
Candidate Information)

Describe prior training and research efforts, and how they relate
to the objectives and long-term career plans of the candidate.

Provide evidence of the candidate's potential to develop into a
successful independent investigator. Usually this is evident from publications,
prior research interests and experience, and letters of reference.

For individuals in postdoctoral positions with other titles
although still in non-independent training positions, describe evidence of
non-independence.

Describe the candidate’s commitment to a career in a biomedical
or behavioral research field relevant to the mission of the NHLBI.

Career Goals and Objectives
(Component of Candidate Information)

Describe a systematic plan that shows a logical progression from
prior research and training experiences to the research and training
experiences that will occur during the K22 award period and then to independent
investigator status.

Candidates planning to be sponsored by an NHLBI intramural
laboratory for the intramural phase should select a mentor with whom the
candidate can consult in preparing and submitting the application for the intramural
phase of the award. Individuals working at an NHLBI laboratory may work with
their current mentor, or with another intramural investigator, provided the
research experience proposed in this application will enhance the candidate's
scientific career. Candidates needing assistance should contact the Office of
Education at direducation@nhlbi.nih.gov and submit a curriculum vitae and a brief description of his/her past training,
research experience and research interests as well as future research plans.

Career Development/Training
Activities During Award Period (Component of Candidate Information)

The candidate and the mentor are jointly responsible for the
preparation of the career development plan.

A timeline is often helpful. The sponsor/mentor may form a
mentoring team (or an Advisory Committee).

Provide a description of the career development plan,
incorporating consideration of the candidate's goals and prior experience. Include
a plan to obtain the necessary research experience to launch an independent
research career.

The career development plan must be tailored to the needs of the
individual candidate and the ultimate goal of achieving independence as a
researcher.

Candidates must justify the need for both the intramural phase
and the extramural phase, and must provide a convincing case that the proposed
period of support (1-2 years as a mentored candidate followed by up to 3 years
as an independent scientist) will substantially enhance his/her career and/or
will allow the pursuit of a novel or promising approach to a particular
research problem.

The candidate and the mentor must describe the plan for
evaluation of his/her progress during the intramural phase and for the
transition to the extramural phase.

The candidate and the intramural mentor must describe plans for
the transition to the extramural phase.

Training in the Responsible Conduct of Research (Component of Candidate Information)

Individuals are required to comply with the
instructions for Training in the Responsible Conduct of Research as provided in
Chapter 7 of the SF424 (R&R) Application Guide

The candidate must name a primary mentor (sponsor), an
investigator in the Division of Intramural Research at NHLBI, who, together
with the candidate, is responsible for the planning, direction, and execution
of the program. The candidate may also identify co-mentors as appropriate to
the goals of the program.

The mentor(s) should be recognized as an accomplished
investigator in the proposed research area and have a track record of success
in training individuals in postdoctoral positions who have gone on to become
independent investigators.

Signed statements must be provided by all consultants/collaborators
confirming their participation in the project and describing their specific
roles. Collaborators and consultants generally do not need to provide their
biographical sketches. However, information should be provided clearly
documenting the appropriate expertise in the proposed areas of
consulting/collaboration. Collaborators/consultants are generally not directly
involved in the development of the career of the candidate as an independent
investigator.

The application must include a statement from the mentor
providing: (1) information on his/her research qualifications and previous experience
as a research supervisor; (2) a plan that describes the nature of the
supervision and mentoring that will occur during the proposed award period,
including how the candidate’s scientific and professional independence will be
promoted; (3) a description of the elements of the planned research career
development, including any formal course work; and (4) a plan for transitioning
the candidate to move from the mentored stage of his/her career to the
independent research investigator status during the project period of the
award.

The mentor(s) must agree to provide annual evaluations of the
candidate’s progress as required in the annual progress report.

Description of Institutional
Environment (Component of Environment and Institutional Commitment to the
Candidate)

The NHLBI mentor must define and document a strong,
well-established research and career development program related to the
candidate's area of interest, including a high-quality research environment
with staff capable of productive collaboration with the candidate. The NHLBI
Scientific Director must provide a statement of commitment to the candidate's
development into a productive, independent investigator and to meeting the
requirements of this award.

In addition, the NHLBI Scientific Director's statement should:

Describe
the resources and facilities that will be available to the candidate.

Describe
how NHLBI environment is particularly suited for the development of the
candidate's research career and the pursuit of the proposed research plan.

Provide
assurances that the candidate will be able to devote 100% professional effort
to the development of a research program.

Research Strategy (Component of
Research Plan)

A sound research project that is consistent with the candidate’s
level of research development and objectives of his/her career development plan
must be provided. The research description should demonstrate not only the
quality of the candidate’s research thus far but also the novelty,
significance, creativity and approach, as well as the ability of the candidate
to carry out the proposed research.

The application must also describe the relationship between the
mentor’s research and the candidate’s proposed research plan. If more than one mentor is proposed, the respective areas of expertise and responsibility
should be described.

The application must include a description of how the intramural
phase research will lead to the extramural phase research.

Appendix

Do not use the Appendix to circumvent page limits.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Letters of Reference

Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when letters of reference will
be accepted. Applications lacking the appropriate, required reference letters will
not be reviewed (more details in the Notice).
This is a separate process from submitting an application electronically. At
least three but not more than five reference letters are submitted directly
through the eRA Commons
Submit Referee Information link and not through Grants.gov.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants are
responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of on-time submission are
provided in the SF424 (R&R) Application Guide.

Research expenses including personnel, consultants,
equipment, supplies, and travel will be negotiated with the laboratory chief
and will depend on the nature and scope of the research approved by peer
review.

Extramural Phase:

Allowable research expenses include (1) research expenses,
such as supplies, equipment, and technical personnel; (2) travel to research
meetings or training; and (3) statistical services, including personnel and
computer time. The research development support costs must be justified and be
consistent with the stage of development of the candidate and the proportion of
time to be spent in research or career development activities.

6. Other Submission Requirements
and Information

Applications must be submitted electronically following the
instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

For assistance with your electronic application or for
more information on the electronic submission process, visit Applying
Electronically.

Important reminders:All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers should provide their assessment of the likelihood
for the candidate to maintain a strong research program, taking into
consideration the criteria below in determining the overall impact/priority
score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Candidate

Does the candidate have the potential for becoming a
successful independent investigator who will contribute significantly to a
chosen health-related research field? Will the research experiences in the
intramural phase prepare the candidate to implement successfully the extramural
phase research project? Do the letters of reference from at least three
well-established scientists address the candidate's potential for becoming an
independent investigator? Given the candidate’s prior training, proposed career
development plan, and the referees’ evaluations, is it reasonable to expect
that the candidate will be able to achieve an independent, tenure-track or
equivalent position within the time period requested for the intramural phase
of this award?

Career Development Plan/Career Goals
& Objectives

To what extent are the plans for evaluating the
awardee’s progress adequate and appropriate for guiding the applicant towards a
successful transition to the extramural phase of the award? Is the timeline
planned for the transition to the extramural phase of the award appropriate for
the candidate’s current stage of scientific and professional development and
the career development proposed for the phase of the award? What is the
likelihood that the plan will contribute substantially to the scientific
development of the candidate leading to scientific independence? Are the
candidate's prior training and research experience appropriate for this award? Are
the content, scope, phasing, and duration of the career development plan
appropriate when considered in the context of prior training/research
experience and the stated training and research objectives for achieving
research independence? Are there adequate plans for monitoring and evaluating
the candidate’s research and career development progress?

Research Plan

Is the proposed research project appropriate for the
candidate’s stage of research development and as a vehicle for development of the
research skills described in the career development plan? Are the scientific
and technical merits of the research question, design, and methodology
appropriate in the context of prior training and experience? Is the proposed
research relevant to stated career objectives?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Are the mentor's research qualifications in the area
of the proposed research appropriate? Do(es) the mentor(s) adequately address
the candidate’s potential and his/her strengths and areas needing improvement? Is
there adequate description of the quality and extent of the mentor’s proposed
role in providing guidance and advice to the candidate? Is the mentor’s
description of the elements of the research career development activities,
including formal course work adequate? Is there evidence of the mentor’s,
consultant’s, collaborator’s previous experience in fostering the development
of independent investigators? Is there evidence of previous research
productivity and peer-reviewed support? Is active/pending support for the
proposed research project appropriate and adequate? Are there adequate plans
for monitoring and evaluating the career development awardee’s progress toward
independence? Do the proposed consultant(s)/collaborator(s) provide the
required expertise for successful conduct of the research project? Is adequate
information provided that clearly documents expertise in the proposed area(s)
of consulting/collaboration? Have the proposed consultant(s) and
collaborator(s) provided evidence of commitment to the candidate and the
candidate's project?

Environment & Institutional
Commitment to the Candidate

INTRAMURAL PHASE

Are there adequate and appropriate research facilities and educational
opportunities, including collaborating faculty? Is there clear commitment of
the sponsoring institution to ensure that the required effort of the candidate
will be devoted directly to the research training, career development, and
research activities described in the proposed career development and research
plans? Is there strong institutional commitment to fostering the career
development of the candidate? Are there unique features of the scientific
environment that benefit the proposed research; e.g., useful collaborative
arrangements or subject populations? Is the environment of high quality and
relevance for scientific and professional development of the candidate?

What is the quality of NHLBI Scientific Director's statement of
the resources and facilities that will be available to the candidate.

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: (1) the justification for the exemption, (2) human
subjects involvement and characteristics, and (3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the following
five points: (1) proposed use of the animals, and species, strains, ages, sex,
and numbers to be used; (2) justifications for the use of animals and for the
appropriateness of the species and numbers proposed; (3) adequacy of veterinary
care; (4) procedures for limiting discomfort, distress, pain and injury to that
which is unavoidable in the conduct of scientifically sound research including
the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable
restraining devices; and (5) methods of euthanasia and reason for selection if
not consistent with the AVMA Guidelines on Euthanasia. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct
of Research

Taking into account the circumstances of the
candidate, including level of experience, the reviewers will address the
following questions. Does the plan satisfactorily address the format of
instruction, e.g., lectures, coursework, and/or real-time discussion groups?
Do plans include a sufficiently broad selection of subject matter, such as
conflict of interest, authorship, data management, human subjects and animal
use, laboratory safety? Do the plans adequately describe the role of the
sponsor/mentor or other faculty involvement in the candidate’s instruction?
Does the plan meet the minimum requirements for RCR, i.e., eight contact hours
of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of
the review committee.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the NHLBI, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned to the NHLBI for peer review and potential funding.. Applications will compete for available funds with
all other recommended applications . Following initial peer review, recommended
applications will receive a second level of review by the NHLBI Advisory Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

There will not be a formal Notice of Award (NoA) associated with the mentored
phase of the K22 award conducted in the NHLBI intramural program. The NHLBI
will transmit to the successful candidate an approval letter that will include
the terms and conditions of the NHLBI intramural K22 award, as well as
expectations for the transition to the extramural phase of the award.

A formal Notice of Award (NoA) will be provided as part of
the extramural phase of the K22 award conducted at a domestic, sponsoring
extramural institution/organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page).

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Transition from the intramural phase to the extramural phase
is not automatic. Approval of the transition will be based on the success of
the awardee’s research program as determined by annual scientific reviews and
by the evaluation of a research and career development plan to be carried out
at the institution. Additionally, the sponsoring institution must demonstrate a
commitment to the candidate by providing a minimum of nine person-months
(75% full time professional effort) protected research time, space and
resources needed to conduct the proposed research project and appropriate
scientific mentoring. A plan for career development that will lead to research
independence and the ability to successfully compete for research support is
essential. The NHLBI will conduct a transition review no later than three
months before the end of the intramural phase.

Candidates must provide a progress report using form PHS 2590,
which should detail progress achieved on the specific aims of the Research Plan
and on the pursuit of identified career and career development goals. Future
goals for the research project and for further career development should also
be indicated. The mentor of the intramural phase must provide a separate
narrative of the research and career development of the candidate.

The extramural phase institution will submit an application
on behalf of the candidate for the K22 award using the SF-424. These materials
should be sent directly to the NHLBI (tm275a@nih.gov).
The original application plus one copy (preferably in a PDF format) are to be
mailed to the Financial/Grants Management contact person of the NHLBI listed in
this FOA. The SF-424 application must include the following:

A brief description of plans to address the specific aims.

A description of the institutional environment, including:
research facilities and the availability of appropriate educational
opportunities, including collaborating faculty, when necessary; quality and
relevance of the environment for scientific and professional development of the
candidate.

Information about the sponsoring institution’s commitment to the
candidate and to the candidate’s scientific independence, including: commitment
to ensuring that the candidate’s effort required by the K22 program will be
devoted directly to the research development activities described in the
proposed research plans; institutional commitment to fostering the career
development of the candidate.

Position Description: the institution should provide a detailed
description of the candidate’s position, responsibilities, and duties. The
institution’s tenure-track policy should be defined or a description should be
provided of the equivalent arrangements for institutions without a formal
tenure-track.

Evidence that the awardee has a Tenure Track Advisory Committee
to enhance their career trajectory and assist in skill development other than
scientific research (e.g., scientific management, administrative, and teaching
responsibilities).

Budget in detail, including justification for all requested
funds:

List the name, role on project and
percent effort for all project personnel (salaried and unsalaried) and provide
a narrative justification for each person.

Identify all consultants by name and
organization affiliation and describe the services to be performed.

Provide a narrative justification for
any major budget items, other than personnel, that are requested for the
conduct of the project.

Describe specific resources committed
by the sponsoring institution to support the Candidate’s research.

The awardee’s progress will be evaluated on an annual basis
by the mentor, Laboratory Chief, and Scientific Director and continued support
will be approved by the intramural administrative officer.

Extramural
Phase:

The Progress Report must include Sections (A) through (F) as
described in Section 2.2.6 (Progress Report Summary) in the general PHS form
2590 instructions, as well as sections G through J as described in Section 5 of
the 2590 instructions. Evaluation of the awardee’s progress for transition will
encompass the following:

A demonstration of scientific progress toward the aims of
the research as described in a brief summary of the studies and results
obtained during the prior funding period.

A description of career development and research-related
activities undertaken during the prior funding period.

A list of accomplishments such as publications (in press or
submitted), scientific presentation, new collaborations, inventions, or
project-generated resources made during the prior funding period.

A brief explanation of plans to address the specific aims
during the next year of support.

A description of proposed career development and
research-related activities for the next year of support with a clear
indication of percent effort devoted to research/research training and other
activities.

An annual evaluation statement of the candidate's progress
by the sponsor (usually the department chair for K22 awardees in the extramural
phase), as required in the PHS 2590 continuation application instructions (item
J. Sponsor's Report).

List all applications submitted for investigator-initiated
research grant support.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for closeout
of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.